How we manage advertising compliance

These principles guide our advertising compliance processes:

• Providing education resources to assist advertisers to manage their compliance obligations.
• Focusing our resources on alleged non-compliance that presents the highest risks to public health, safety, and confidence in our regulations.
• Taking compliance and enforcement actions proportionate to the level of non-compliance and the level of harm that may result from the advertiser's actions.
• Ensuring our compliance and enforcement actions are evidence-based and informed by the types of behaviours identified, including demonstrated willingness of the advertiser to become and remain compliant.
• Showing our commitment to transparency by reporting on enforcement actions and compliance outcomes.

We take non-compliance with the regulatory scheme seriously, especially where a breach of the advertising requirements has resulted in, or poses, a threat to public health and safety. 

A range of compliance and enforcement tools are available to address non-compliance and may include criminal or civil court proceedings, which can result in substantial penalties, fines, or imprisonment.

Advertisers are obligated to ensure that their advertisements are compliant with legal requirements. These are our main regulatory approaches to managing compliance.

Education

We educate advertisers, consumers, health professionals and industry to promote voluntary compliance with our advertising requirements. 

We provide information that:

• raises awareness of advertiser’s legal obligations
• helps advertisers understand how to comply and meet their obligations
• keeps advertisers updated on changes to the requirements
• empowers consumers to recognise non-compliant advertising
• informs consumers how to report suspected non-compliance.

We achieve this through a range of channels as outlined in the Therapeutic goods import, advertising and supply compliance education strategy.

Detection and assessment

We use a combination of our own monitoring activities and community reports of suspected breaches to collect information on alleged non-compliant advertising for assessment and triage.

Reported non-compliance, assessment and case selection

We receive reports of suspected advertising non-compliance from community members through online forms.

Community reports are held in strict confidence, and we do not release information about compliance and enforcement activities – such as current investigations – unless required by the investigative process or in the public interest.

Once received, a report is assessed by considering:

• our jurisdiction to take action 
• the risk of harm to consumers
• the nature of the breach
• the vulnerability of the target market
• alignment with the advertising compliance priorities
• the size, reach and compliance history of the advertiser.

We use this risk assessment to decide if the report is converted into a case for immediate investigation or is recorded for intelligence purposes and for investigation later.

Case outcomes can be found at Advertising investigation outcomes.

Selecting matters for investigation

Investigations into alleged non-compliance will be determined on whether the matter: 

• is related to an annual compliance priority and part of the associated compliance operation
• is related to a compliance operation that arises during the year
• is of higher risk and selected as an individual case for investigation
• has been selected for action from a lower risk report stored in our database.

Advertising compliance priorities

Our Import, Advertising and Supply Compliance Priorities are reviewed regularly. You can find the latest version in the Compliance and enforcement hub.

The Department of Health's Corporate Plan and TGA Business Plan set out the Department's and the TGA's strategic priorities and intended results. 

To identify compliance priorities, we collect and analyse data from a range of information sources, including: 

• community feedback
• co-regulators and industry partners including the Therapeutic Goods Advertising Consultative Committee 
• results from monitoring activities
• trends in non-compliance
• open-source information.

Response

Our response to advertising non-compliance is relative to risk and the nature of the breach. It is determined on a case-by-case basis.

A range of actions may be applied:  

• education and guidance
• administrative responses, including warnings or cautions
• negotiating an enforceable undertaking
• seeking an injunction
• issuing a direction notice, infringement notice or public warning notice
• cancelling or suspending a product from the Australian Register of Therapeutic Goods (ARTG), or recalling goods 
• pursuing criminal prosecution or civil penalties.

Where appropriate, an advertising case may require consideration of other breaches of the Act, including import, manufacturing or supply offences.

You can find more information on the compliance actions available to us at Compliance actions and outcomes.

Measure and report

We measure and report on our performance to ensure accountability and continued improvement.

We assess ongoing compliance across a sample of closed cases, which are made up of both cases identified for monitoring and random selection. 

The sampling includes cases from compliance operations and individual cases that were selected for investigation.

We are committed to transparency and offers several reports on our regulatory functions. Outcomes from advertising investigations can be found at Advertising investigation outcomes.

Performance information is reported in the annual Regulator Performance Framework reports.